BEUDAMED
    FDA Adverse Event Summary report: N

    530G INSULIN PUMP MMT-751NAL

    MDR report key: 4141293 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-92122
    Date Received
    October 3, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAS A BUTTON ERROR ON THEIR INSULIN PUMP AND BUTTONS ARE UNRESPONSIVE. PATIENT'S BLOOD GLUCOSE LEVEL IS 181 MG/DL. TROUBLE SHOOTING IS CONDUCTED AND FOUND THAT CUSTOMER WAS PUSHING THE BUTTONS FAST. DEVICE IS BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619851 530G INSULIN PUMP MMT-751NAL OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR